Michael Flagg Email & Phone Number

Columbia, Mo, Us

Columbia, Mo, Us

Columbia, Missouri, United States

In this role I provide executive oversight on all matters related to isotope supply in support of API and radiopharmaceutical manufacturing for the BWXT Medical enterprise. In addition, I work with executive colleagues on business development programs as well as provide isotope production concepts for consideration. This entails leading negotiation of isotope supply agreements with private and state-owned enterprises and managing these critical relationships on a day to day basis.

Columbia, Missouri, United States

Responsible for client programs\studies from initial acceptance of quote through project completion. I work closely with operations, test designers, protocol writers and commercial staff to ensure clients programs are scheduled and work is completed to provide overall client satisfaction.

Columbia, Missouri Area

Responsible for the operations, outcomes and P&L for the BioPharma Services USA research facility. This included ensuring the team had the tools to produce high quality clinical trial studies, while meeting time and cost expectations. My role covered all staffing decisions, oversight and mentoring of our team, direction of the planning, development, implementation, execution, and management of clinical trials hosted at our site, as well as overseeing continuous improvements in quality and study processes.

Columbia, Missouri Area

Responsible for the success of a portfolio of development projects and the managers who ran them. The Special Projects team operated as a bridge organization - taking radioisotope and radiopharmaceutical production projects from the bench-scale or proof of principle phase, evaluated how best they could be scaled up, and transitioned them to applied R&D and early commercialization stages.Additional responsibilities included overseeing the IT and Document Control service functions and serving as necessary on oversight and management task forces and committees.This department supported corporate, federal, and in-house research projects in the transition from bench-top to routine production and assist business development efforts as needed to provide the tools our customers and partners need to take ideas to market.Key Accomplishment: Directed efforts to move a pilot scale n-gamma Mo-99 production plant to commercial scale, accompanied by the filing of a Drug Master File with US FDA. Plant was qualified for production and the DMF filed on time and on budget. Also established the program for the build-out of an I-131 production facility.

Columbia, Mo

Responsible for the successful implementation of a portfolio of radioisotope product development projects. Directed a team of project managers taking these projects from the lab to routine production status. Duties expanded to include responsibility for the efforts of the Computer Services group to support the routine IT needs of the organization as well as implement new equipment and infrastructure.Key Accomplishment: Led the effort to transition a pilot scale Lu-177 production plant to commercial scale, accompanied by the filing of a DMF. Plant was qualified for production and the DMF filed on time and on budget.

Columbia, Missouri

This position entailed work as a project manager, program manager and technical/regulatory consultant at the reactor. Key projects/programs that were led to successful conclusions in this role include:1. Upgrade of a radiochemical API manufacturing process to cGMP standards2. Program manager for the acquisition of a new Type B Package fleet to 10CFR71 standards3. Engineering analysis and project support to scope out the implementation of reactor-based Mo-99 production at MURR4. Supported Los Alamos National Laboratory (LANL) and the International Atomic Energy Agency (IAEA) on SSAC and DIQ nuclear safeguards and non-proliferation training courses hosted at MURR in 2007 and 2009

Research Assistant at the University of Missouri - Rolla Reactor and to nuclear engineering faculty during winter and fall semesters. Summer 2003 (Argonne National Lab): Engineering intern with duties that included rewriting computer programs and analyzing data for the Reactor Engineering Assessment division. Summer 2004 (UMR, et al): Technical liaison for the University of Missouri System to a consortium formed to bid on a multi-billion dollar M&O contract for a DOE National Laboratory.Summer 2005 (Westinghouse): Intern in the PWR Core Technologies Division in Pittsburgh. Responsibilities included using proprietary nuclear fuel modeling software to analyze fuel rod performance, comparison of heat transfer models and analysis of the effects of enrichment and material composition on fuel rod temperatures and internal pressures. Completed the Fuel Rod Design Training Course (FR200).

Headed a team that provided back-office services for over 100 mutual funds. Services included transaction processing, data warehousing, calculation of broker compensation, and all associated functions necessary to support financial record-keeping for mutual funds.My team was on-call 24/7. We addressed all business-critical problems and, due to the nature of processing transactions, fixes had to be made quickly and accurately. In addition, we provided ad hoc reporting and worked on small projects.My position was to manage this activity, communicate with the client and code my share of projects and fixes.

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